Harbour BioMed, a global biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) of China has accepted its Biologics License Application (BLA) for batoclimab in the treatment of generalized myasthenia gravis (gMG). This marks the first BLA accepted by NMPA since Harbour BioMed's establishment. Batoclimab is an innovative therapy targeting anti-FcRn treatment and has shown positive results in clinical development, confirming its efficacy and safety in Chinese gMG patients.
The acceptance of the BLA by NMPA demonstrates Harbour BioMed's strong research and development capability. The success of batoclimab sets a milestone for the development of innovative therapeutics in the treatment of gMG. The company is excited to bring this much-needed drug to patients and will continue advancing its pipeline of next-generation therapeutics to fulfill unmet medical needs.
Batoclimab received the "Breakthrough Therapy Certificate" from NMPA in 2021 and achieved positive outcomes in proof-of-concept studies and phase III clinical trials. In